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Trial record 1 of 1 for:    NCT02008786
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Statin and Angiotensin-converting Enzyme Inhibitor on Symptoms in Patients With SCAD (SAFER-SCAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02008786
Recruitment Status : Recruiting
First Posted : December 11, 2013
Last Update Posted : August 10, 2018
Information provided by (Responsible Party):
Dr. Tara Sedlak, Cardiology Research UBC

Brief Summary:
An emerging cause of heart attack in young women is a dissection (or tear) in the coronary arteries. Many of these young women continue to have chest pain long after the tear has healed and this is thought to be due to problems with their small blood vessels of the heart (or microcirculation). We want to determine whether commonly used medications for coronary artery disease including statins (for cholesterol) and angiotensin-converting enzyme inhibitors (for blood pressure) reduce chest pain and improve small vessel function in these patients.

Condition or disease Intervention/treatment Phase
Coronary Artery Dissection, Spontaneous Drug: ramipril Drug: rosuvastatin Drug: placebo Phase 4

Detailed Description:

In patients with spontaneous coronary artery dissection (SCAD), many continue to have ongoing signs and symptoms of ischemia after the dissection has healed. Further, 1 in 5 women will experience recurrent SCAD in long-term follow-up. To date, no study has investigated the pathophysiologic mechanism behind ongoing symptoms or recurrence of SCAD, but microvascular coronary dysfunction (MCD) has been suggested. Coronary reactivity testing (CRT) is an invasive procedure currently being done in MCD patients as the gold standard technique. In particular, a coronary flow reserve (CFR) < 2.5 has been shown to be both diagnostic of the condition and prognostic of a 2 fold increased risk of cardiac events. Please see below for a detailed description of CRT. In brief, a dual temperature and pressure sensor tipped wire by Radi Medical Systems (St Jude Medical, St Paul, MN) will be placed into the dissected and non-dissected coronary arteries of the patient. This will measure CFR by thermodilution and will also allow the measurement of the index of microcirculatory resistance (IMR). IMR has been found to correlate well with true microvascular resistance.

In addition to a lack of diagnostic strategies, there is a paucity of research into therapeutic strategies. Most women are conservatively managed with medications, however, there is no consensus as to which pharmacologic therapies should be used. Case reports have suggested benefit with antiplatelet agents (e.g. aspirin) and beta-blockers (reduction of arterial wall shear stress). To date no study has investigated the effects of statins or Angiotensin Converting Enzyme Inhibitors (ACEIs) in SCAD patients. Both agents have been studied in the MCD population and been found to reduce angina frequency and improve CFR after 16 weeks.


To measuring the CFR and IMR in 40 SCAD patients with ongoing chest pain who are at least 3 months from their dissection to determine the proportion with microvascular dysfunction and to investigate prospectively whether the addition of an ACEI or a statin to usual care in patients with ongoing chest pain and a CFR <3.0 improves chest pain frequency by Seattle Angina Questionnaire (SAQ) at 16 weeks compared to placebo.


We hypothesize that the average CFR in patients at least 3 months out from their SCAD will be <2.5 and that their IMR will be abnormal. Further, we hypothesize that the addition of either an ACEI and/or statin will improve chest pain frequency by at least 20 points on the SAQ at 16 weeks compared to placebo.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Statin and Angiotensin-converting Enzyme Inhibitor on Coronary Flow Reserve, indEx of Microcirculatory Resistance, and Symptoms in Patients With Spontaneous Coronary Artery Dissection (SAFER-SCAD) Study
Study Start Date : June 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Rosuvastatin, placebo
rosuvastatin 10-20mg daily or placebo (suggested dose of 10mg for Asians, and 20mg for others)
Drug: rosuvastatin
10-20mg (suggested dose 10mg for Asians, 20mg for everyone else)
Other Name: crestor

Drug: placebo

Experimental: Ramipril, placebo
ramipril (starting dose of ramipril at 5mg daily titrating up to 10mg daily at 1 week if tolerated) versus placebo
Drug: ramipril
5-10mg (starting dose 5mg titrating up to 10mg if tolerated after 1 week)
Other Name: Altace

Drug: placebo

Primary Outcome Measures :
  1. Angina frequency domain of the SAQ [ Time Frame: 16 weeks after each intervention ]
    Angina frequency domain of the SAQ, collected at baseline and after each intervention to assess angina frequency change over time. We hypothesize that mean SAQ will improve by at least 20 points in each treatment group compared to placebo.

Secondary Outcome Measures :
  1. Acute coronary syndrome or hospitalization for angina [ Time Frame: 1 year ]
    As a secondary objective, to evaluate whether ACEI or statin versus placebo reduces the combined endpoint of acute coronary syndrome (ACS) or hospitalization for angina at 52 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Any woman with prior SCAD who is at least 3 months out from her SCAD and has ongoing symptoms of chest pain.
  • Females of child-bearing age must have a negative pregnancy test at enrollment
  • Coronary Flow Reserve(CFR) < 3.0

Exclusion Criteria:

  • Renal dysfunction with Glomerular Filtration Rate <50 ml/min
  • Patients not willing to undergo coronary angiography
  • Patients with a prior intolerance or allergy to rosuvastatin or ramipril
  • Inability to perform CRT or CFR >3.0
  • Obstructive coronary artery disease (stenosis >50% in any artery) or residual dissection >50% with distal flow abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02008786

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Contact: Tara L Sedlak, MD 604-875-5487
Contact: Andrew Starovoytov, MD 604 875 5079

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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Tara L Sedlak, MD    604-875-5487   
Principal Investigator: Jacqueline Saw, MD         
Principal Investigator: Tara Sedlak, MD         
Sponsors and Collaborators
Cardiology Research UBC
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Principal Investigator: Tara Sedlak, MD University of British Columbia
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Responsible Party: Dr. Tara Sedlak, Cardiologist, Cardiology Research UBC Identifier: NCT02008786    
Other Study ID Numbers: SAFER-SCAD
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Keywords provided by Dr. Tara Sedlak, Cardiology Research UBC:
Coronary Artery Dissection, Spontaneous
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Coronary Vessel Anomalies
Vascular Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents